Intern, Regulatory Affairs, US Global Rare Diseases

Company Mission :

• We want to be recognized as an international group focused on research, able to develop and commercialize innovative therapeutic solutions to improve the quality of people's lives who suffer from rare disease.
• We intend to maintain a high-quality entrepreneurial team, characterized by a spirit of cooperation and self-confidence.
• Our goal is to combine commitment to results with integrity while operating responsibly from both a social and environmental point of view.

Job Purpose : The Chiesi - Regulatory Affairs internship will be an immersive experience that will include exposure to several regulatory projects directly related to the development of drugs and biologics.

Education and training may include some FDA and Industry Sponsored lectures, but the focus will be a mainly on-the-job training experience.

Summary of Key Responsibilities :

Global Regulatory Affairs Project Coordination :

• Coordinating aspects of communication and activities related to Global Rare Disease project execution
• Prepare agendas and attend internal meetings for internal initiatives and development plans for specific products.
• Coordinate authoring and review of U.S. regulatory submissions
• Quality Assurance and Quality Control review of U.S. regulatory submissions and internal documents
• Maintenance of Global Rare Disease Regulatory Affairs trackers, databases, and other internal resources.

Additional Responsibilities :

Support Regulatory Intelligence Activities

100%

Required Skills :

• A minimum of a Bachelor’s degree in a scientific discipline is required.
• Strong organizational and planning skills
• Strong knowledge of MS Office Suite - Word, Excel, PowerPoint
• Microsoft Project skills a plus
• Exceptional communication in English - verbal and written
• Detail oriented
• Project coordination experience an asset
• Must be detail- and goal-oriented, quality conscientious, and results-oriented.
• An ability to manage changing priorities, multiple tasks, and communicate impact to project teams is required.

Key Competencies :

Organizational Ability Attention to timelines and deadlines. An ability to review and prioritize organizational commitments to maximize productivity across functional groups

Attention to Detail Is thorough when performing work; conscientious about attending to detail; few errors in work performed;

uses logical thinking that is well organized and methodical.

High Productivity Produces consistent, high quality and quantity of outputs and meaningful results that contribute to the agency mission and strategic goal.

Is efficient in producing results that are delivered on time or before. Able to multi-task productively because is well-organized;

applies time management processes and procedures effectively

Teamwork / Collaboration Works toward common goals by supporting, encouraging, and sharing information with colleagues, both internal and external

Communication Speaks, writes, listens, and presents information in a logical and articulate manner appropriate for the audience.